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Published in: Intensive Care Medicine 4/2005

01-04-2005 | Original

Antibiotic prophylaxis of early onset pneumonia in critically ill comatose patients. A randomized study

Authors: A. Acquarolo, T. Urli, G. Perone, C. Giannotti, A. Candiani, N. Latronico

Published in: Intensive Care Medicine | Issue 4/2005

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Abstract

Objective

To evaluate if a 3-day ampicillin-sulbactam prophylaxis can reduce the occurrence of early-onset pneumonia (EOP) in comatose mechanically-ventilated patients.

Design

This was a single-centre, prospective, randomised, open study.

Setting

A 10-bed general-neurological ICU in a 2,000-bed university hospital.

Patients and participants

Comatose mechanically-ventilated patients with traumatic, surgical or medical brain injury.

Interventions

Patients were randomized to either ampicillin-sulbactam prophylaxis (3 g every 6 h for 3 days) plus standard treatment or standard treatment alone.

Measurements and results

Main outcome was the occurrence of EOP. Secondary outcome measures were occurrence of late-onset pneumonia, percentage of non-pulmonary infections and of emerging multiresistant bacteria, duration of mechanical ventilation and of ICU stay and ICU mortality. Interim analysis at 1 year demonstrated a statistically significant reduction of EOP in the ampicillin-sulbactam group, and the study was interrupted. Overall, 39.5% of the patients developed EOP, 57.9% in the standard treatment group and 21.0% in the ampicillin-sulbactam group (chi-square 5.3971; P =0.022). Relative risk reduction of EOP in patients receiving ampicillin-sulbactam prophylaxis was 64%; the number of patients to be treated to avoid one episode of EOP was three. No differences in other outcome parameters were found; however, the small sample size precluded a definite analysis.

Conclusions

Antibiotic prophylaxis with ampicillin-sulbactam significantly reduced the occurrence of EOP in critically ill comatose mechanically ventilated patients. This result should encourage a large multicenter trial to demonstrate whether ampicillin-sulbactam prophylaxis reduces patient mortality, and whether antibiotic resistance is increased in patients receiving prophylaxis.
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Metadata
Title
Antibiotic prophylaxis of early onset pneumonia in critically ill comatose patients. A randomized study
Authors
A. Acquarolo
T. Urli
G. Perone
C. Giannotti
A. Candiani
N. Latronico
Publication date
01-04-2005
Publisher
Springer-Verlag
Published in
Intensive Care Medicine / Issue 4/2005
Print ISSN: 0342-4642
Electronic ISSN: 1432-1238
DOI
https://doi.org/10.1007/s00134-005-2585-5

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